Diabetes Mellitus Clinical Trial
Official title:
Turning Corners: Prosthetic Components and Stability in Amputee Gait
The biomechanics of changing direction while walking has been largely neglected despite its
relevancy to functional mobility. In addition, an increased risk of injury can be associated
with turning due to a decrease in stability. The objective of this study is to understand
the biomechanics of turning gait in sample populations of intact and trans-tibial amputees
and the capacity of prosthetic components to facilitate transverse plane movement. The
clinical impact of this investigation is the development of interventions that increase
functional mobility, stability and safety while turning.
The researchers propose to investigate three sets of hypotheses. The first set addresses the
fundamental biomechanical mechanisms associated with walking along a circular trajectory,
how intact subjects differ from amputees, and the effect of a rotation adaptor pylon. The
second set of hypotheses addresses dynamic stability and the potential influence of
prosthetic interventions. The third set of hypotheses addresses how the rotational
properties of the prosthetic pylon can influence comfort and mobility during daily
activities.
Most of what is known about how amputees walk and how the properties of prosthetic
components affect their gait has been discovered through sagittal plane observations while
amputees walk back and forth along a straight line. Abnormal limb loading, thought to be a
principal factor in the occurrence of residual limb pain which in turn may cause instability
and limit mobility, can certainly occur while walking in a straight line. However, the
incidence of abnormal limb loading is likely amplified when performing more complex gait
activities, such as turning or avoiding obstacles; activities that are so very common in
everyday life.
The specific aims of this investigation are to:
1. discover the biomechanical strategies used and the stability of both intact individuals
and trans-tibial amputees walking along a circular trajectory and
2. explore the effects of a prosthetic intervention on turning biomechanics, stability,
comfort, and mobility.
We propose to investigate three sets of hypotheses:
The first set of hypotheses addresses the fundamental biomechanical mechanisms associated
with walking along a circular trajectory, how intact subjects differ from amputees, and the
effect of a rotation adaptor pylon. We will conduct experiments to test three hypotheses
related to achieving a change of heading, orientation, and balancing of centripetal forces
necessary to walk along a circular trajectory.
The second set of hypotheses seeks to identify whether trans-tibial amputees with a rigid
pylon are more unstable during a turning task than non-amputees and whether or not the
rotation adaptors enhance stability. We will conduct experiments to calculate an index of
dynamic stability that measures the rate at which a person can respond to a perturbation and
return to a stable gait pattern.
The third set of hypotheses addresses how the rotational properties of the prosthetic pylon
can influence comfort and mobility during daily activities. To measure comfort and mobility,
we will solicit questionnaire responses and step count measures from amputees after a
one-month period of wearing a rigid pylon and after a one-month period of wearing a
transverse plane rotation adaptor (within-subject comparison). In addition to these field
measurements, we will also compare the distance traveled during a six-minute walk. Patient
opinions about their prosthesis and mobility measures over long periods of time can play a
significant role in prosthesis evaluation.
For veteran amputees who experience discomfort and increased risk for residual limb skin
problems, it seems reasonable to suppose that these problems might occur when walking along
a curved trajectory rather than just a straight line. The joint forces and moments of
turning may differ significantly from those exhibited while walking in a straight line. The
proposed research will create a new knowledge base with which to understand prosthetic
intervention effectiveness. The immediate clinical impact for the trans-tibial amputee is
the determination if transverse plane rotational adapter pylons can improve their comfort,
mobility, and stability.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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